Label: OMEPRAZOLE capsule, delayed release

  • NDC Code(s): 65841-759-01, 65841-759-05, 65841-759-06, 65841-759-10, view more
    65841-759-16, 65841-760-01, 65841-760-05, 65841-760-06, 65841-760-10, 65841-760-16, 65841-761-01, 65841-761-05, 65841-761-06, 65841-761-10, 65841-761-16
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 27, 2023

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  • MEDICATION GUIDE

  • SPL MEDGUIDE

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 65841-759-01 in bottle of 100 Capsules

    Omeprazole Delayed-release Capsules USP, 10 mg

    Rx only

    100 Capsules

    Omeprazole DR Capsules, 10 mg

    NDC 65841-760-01 in bottle of 100 Capsules

    Omeprazole Delayed-release Capsules USP, 20 mg

    Rx only

    100 Capsules

    Omeprazole DR Capsules, 20 mg

    NDC 65841-761-01 in bottle of 100 Capsules

    Omeprazole Delayed-release Capsules USP, 40 mg

    Rx only

    100 Capsules

    Omeprazole DR Capsules, 40 mg
  • INGREDIENTS AND APPEARANCE
    OMEPRAZOLE 
    omeprazole capsule, delayed release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-759
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACETONE (UNII: 1364PS73AF)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    GELATIN (UNII: 2G86QN327L)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST) (UNII: 8LDD2V82F5)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorPURPLE (AMETHYST PURPLE) , WHITE (WHITE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size10mm
    FlavorImprint Code ZA;09;10mg
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-759-0630 in 1 BOTTLE; Type 0: Not a Combination Product11/23/2012
    2NDC:65841-759-1690 in 1 BOTTLE; Type 0: Not a Combination Product11/23/2012
    3NDC:65841-759-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/23/2012
    4NDC:65841-759-05500 in 1 BOTTLE; Type 0: Not a Combination Product11/23/2012
    5NDC:65841-759-101000 in 1 BOTTLE; Type 0: Not a Combination Product11/23/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09135211/23/2012
    OMEPRAZOLE 
    omeprazole capsule, delayed release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-760
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACETONE (UNII: 1364PS73AF)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    GELATIN (UNII: 2G86QN327L)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST) (UNII: 8LDD2V82F5)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorBROWN (TAN) , WHITE (WHITE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size11mm
    FlavorImprint Code ZA;10;20mg
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-760-0630 in 1 BOTTLE; Type 0: Not a Combination Product11/23/2012
    2NDC:65841-760-1690 in 1 BOTTLE; Type 0: Not a Combination Product11/23/2012
    3NDC:65841-760-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/23/2012
    4NDC:65841-760-05500 in 1 BOTTLE; Type 0: Not a Combination Product11/23/2012
    5NDC:65841-760-101000 in 1 BOTTLE; Type 0: Not a Combination Product11/23/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09135211/23/2012
    OMEPRAZOLE 
    omeprazole capsule, delayed release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-761
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE40 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACETONE (UNII: 1364PS73AF)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    GELATIN (UNII: 2G86QN327L)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST) (UNII: 8LDD2V82F5)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorPURPLE (AMETHYST PURPLE) , WHITE (WHITE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size19mm
    FlavorImprint Code ZA;11;40mg
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-761-0630 in 1 BOTTLE; Type 0: Not a Combination Product11/23/2012
    2NDC:65841-761-1690 in 1 BOTTLE; Type 0: Not a Combination Product11/23/2012
    3NDC:65841-761-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/23/2012
    4NDC:65841-761-05500 in 1 BOTTLE; Type 0: Not a Combination Product11/23/2012
    5NDC:65841-761-101000 in 1 BOTTLE; Type 0: Not a Combination Product11/23/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09135211/23/2012
    Labeler - Zydus Lifesciences Limited (918596198)
    Registrant - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited918596198ANALYSIS(65841-759, 65841-760, 65841-761) , MANUFACTURE(65841-759, 65841-760, 65841-761)
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